FDA.reportPublic FDA data

Burn with Lidocaine

Product NDC
47682-260
11-digit product format
476820260
Labeler code
47682
Product ID
47682-260_3e4ebe6a-8c81-0e41-e063-6394a90a5318
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride, Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Unifirst First Aid Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-24
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE HYDROCHLORIDE
Active strength
1.3; 5 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Burn with Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/g
LIDOCAINE HYDROCHLORIDE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, V13007Z41A
Rxcui1012100

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-260-12Burn with Lidocaine0.9 g in 1 PACKETCREAM0.915
47682-260-12Burn with Lidocaine10 in 1 BOXCREAM1015
47682-260-73Burn with Lidocaine25 in 1 BOXCREAM2515
47682-260-99Burn with Lidocaine0.9 g in 1 PACKETCREAM0.915

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-260-73EA - Each47682-26001549a85-ba36-4df5-822b-afd85f60440112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41ABURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
BenzalkoniumACTIVE MOIETY7N6JUD5X6YBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
LidocaineACTIVE MOIETY98PI200987BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
alcoholINACTIVE INGREDIENT3K9958V90MBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
methylparabenINACTIVE INGREDIENTA2I8C7HI9TBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
paraffinINACTIVE INGREDIENTI9O0E3H2ZEBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
petrolatumINACTIVE INGREDIENT4T6H12BN9UBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
waterINACTIVE INGREDIENT059QF0KO0RBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2
white waxINACTIVE INGREDIENT7G1J5DA97FBURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-260BURN WITH LIDOCAINE (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [UNIFIRST FIRST AID CORPORATION]14Current NDC, Legacy NDC, 4 package rows20240117_81363387-d4b1-4c3f-b67f-5017361c0fcd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN81363387-d4b1-4c3f-b67f-5017361c0fcd15
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD81363387-d4b1-4c3f-b67f-5017361c0fcd15
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY81363387-d4b1-4c3f-b67f-5017361c0fcd15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-260-124768202601210 PACKET in 1 BOX (47682-260-12) / .9 g in 1 PACKET10 packet2017-07-030000-00-00NoNoCurrent
47682-260-734768202607325 PACKET in 1 BOX (47682-260-73) / .9 g in 1 PACKET (47682-260-99) 25 packet2012-01-240000-00-00NoNoCurrent
47682-260-9947682026099.9 g in 1 PACKET (47682-260-99) 2012-01-240000-00-00NoNoCurrent